ANZCTR search results

The aim of the study is to test the effects of a couple based education program (Couple CARE for Parents) with couples having their first baby. We will assign couples to receive Couple CARE for Parents or usual woman focused education and support. We predict that Couple CARE for Parents will enhance couple relationship satisfaction, individual adjustment and parenting.

This clinical trial is for premenopausal and young postmenopausal women who after their breast cancer surgery have been found to have cancer cells in the glands of the armpit (‘positive axillary lymph nodes’) and whose tumours do not have oestrogen receptors (are not stimulated by oestrogen). These tumour characteristics are often associated with a higher risk for breast cancer recurrence. It is known that chemotherapy in standard doses after breast cancer surgery reduces the chance of breast cancer recurrence. However, this clinical trial aims to assess whether giving higher doses of chemotherapy is more effective in killing remaining cancer cells in women with a high risk of recurrence. Women will be allocated randomly (like the toss of a coin) to have either standard chemotherapy for their breast cancer, or high dose chemotherapy.

It is unclear whether patients who do not undergo an axillary dissection and receive further systemic treatment, have a similar prognosis to those with axillary clearance who receive the same therapy. The focus of this international trial is to determine the importance of an axillary node dissection for breast cancer patients 60 years or older who receive Tamoxifen as an ongoing treatment. Particular attention will also be given to the quality of life of the patients over the first six years of the study.

The use of tamoxifen has provided a reduction in deaths due to breast cancer in postmenopausal women with both node-positive and node-negative disease. However, the benefit of tamoxifen treatment may be confined to patients with oestrogen receptor positive disease and a standard adjuvant treatment for all postmenopausal patients with node-positive, oestrogen receptor negative disease has not yet been defined. Results from previous trials have indicated that the combination of CMF and tamoxifen (chemo-endocrine therapy) improved disease-free survival in all postmenopausal patients when compared with CMF or surgery alone. Patients with oestrogen receptor negative disease were found to benefit significantly from the combined treatments. Therefore, IBCSG VII will investigate the effectiveness of adding early combination chemotherapy and late additional chemotherapy to adjuvant tamoxifen compared to administering tamoxifen treatment alone in postmenopausal women.

The optimal duration of adjuvant chemotherapy in premenopausal patients with operable early stage breast cancer is currently unknown and it is thought that relapse of disease following adjuvant therapy may be due to the presence of cells which are non-responsive to first cycles of treatment. Therefore, IBCSG VI will investigate whether 3 cycles of initial adjuvant chemotherapy are as effective as 6 cycles and whether the addition of 3 cycles of chemotherapy after a treatment-free interval is as effective as administering an initial course of chemotherapy alone in premenopausal patients.

This study plans to investigate whether statements made during intravenous induction of anaesthesia with propofol affect the perception of pain on injection.

This study will use the best quality research methods to test whether providing a 6-month individualised exercise and nutrition program to hip fracture patients soon after injury improves walking and other important health outcomes. Patients will be followed for 12 months to determine what difference the exercise and and nutrition programs make. If they help then health services will have the evidence they need to recommend this type of program to the growing number of older Australians that suffer a hip fracture.

The primary purposes of this study are: 1). To test whether HPV 6 virus like particles given as a vaccine are therapeutic for (ie prevent recurrence after conventional destructive treatment, or prolong the interval to recurrence after conventional destructive treatment) recurrent respiratory papillomatosis. 2). To confirm that this experimental vaccine is safe when used in this way. The vaccine is designed to encourage the body’s defences against infection to attack cells infected by HPV. This study will test different doses of the vaccine to see if they work.

The aim of this study is to examine whether the use of acupuncture improves the characteristics of the endometrium associated with implantation and pregnancy. Women will be randomised to receive acupuncture or standard care (control group). Women will be randomised at day 9 subject to the result of ultrasound and blood test. The endometrium will be assessed by vaginal ultrasound and the endometrium thickness and pattern recorded. The ultrasound will be performed by a fertility specialists blind to the study group (routine scan) at day nine to assess timing for egg retrieval. Further ultrasound measurements will be undertaken at the time of Embryo Transfer (ET) and an extra ultrasound undertaken one week following egg retrieval. Routine bloods will be taken prior to egg retrieval and additional blood will be taken on day seven following egg retrieval. Routine measurement of plasma oestradiol and progesterone will be taken. Study group : Treatment with acupuncture Acupuncture points to be used will be selected according to the individual Traditional Chinese Medicine (TCM) diagnosis, and at the time of the first treatment. The second treatment will be administered 25 minutes prior to embryo transfer. Classical acupuncture points pericardium 6 (PC6), Spleen 8 (SP8), Liver 3 (LR3), Stomach 29 (ST29), and Conception vessel (CV4) will be used. Auricular acupuncture points Shenmen, Zhigong, Neifenmi and Naodian will also be used. The third treatment will be administered 25 minutes after embryo transfer using acupuncture points Stomach 36 (ST36), Spleen 6 (SP6), and Spleen 10 (SP10). Auricular points Shenmen, Zhigong, Neifenmi and Naodian will be also be needled. Seirin acupuncture needles will be inserted to tissue level and stimulated manually to elicit the Deqi response. Needles will be retained for 25 minutes in each treatment. Study group 2: Standard care The standard treatment protocols for In Vitro Fertilization (IVF) and embryo transfer will be followed.

To study the safety of Ha44 after topical administration. Safety will be assessed by physical examination, including detailed assessment of scalp, face, eyes and ears, vital signs, 12-lead electrocardiogram, laboratory tests including haematology, clinical chemistry and urinalysis and adverse events. Ha44 is a novel insect ovicide.